Amsterdam International Consensus Meeting: tumor response scoring in the pathology assessment of resected pancreatic cancer after neoadjuvant therapy.

Histopathologically scoring the response of pancreatic ductal adenocarcinoma (PDAC) to neoadjuvant treatment can guide the selection of adjuvant therapy and improve prognostic stratification. However, several tumor response scoring (TRS) systems exist, and consensus is lacking as to which system represents best practice. An international consensus meeting on TRS took place in November 2019 in Amsterdam, The Netherlands. Here, we provide an overview of the outcomes and consensus statements that originated from this meeting. Consensus (≥80% agreement) was reached on a total of seven statements: (1) TRS is important because it provides information about the effect of neoadjuvant treatment that is not provided by other histopathology-based descriptors. (2) TRS for resected PDAC following neoadjuvant therapy should assess residual (viable) tumor burden instead of tumor regression. (3) The CAP scoring system is considered the most adequate scoring system to date because it is based on the presence and amount of residual cancer cells instead of tumor regression. (4) The defining criteria of the categories in the CAP scoring system should be improved by replacing subjective terms including "minimal" or "extensive" with objective criteria to evaluate the extent of viable tumor. (5) The improved, consensus-based system should be validated retrospectively and prospectively. (6) Prospective studies should determine the extent of tissue sampling that is required to ensure adequate assessment of the residual cancer burden, taking into account the heterogeneity of tumor response. (7) In future scientific publications, the extent of tissue sampling should be described in detail in the "Materials and methods" section.

Health care use and remaining needs for support among women with breast cancer in the first 15 months after diagnosis: the role of the GP.

BACKGROUND: The number of women with breast cancer in general practice is rising. To address their needs and wishes for a referral, GPs might benefit from more insight into women's health care practices and need for additional support. OBJECTIVE: To examine the prevalence of health care use and remaining needs among women with breast cancer in the first 15 months after diagnosis. METHODS: In this multicentre, prospective, observational study women with breast cancer completed a questionnaire at 6 and 15 months post-diagnosis. Medical data were retrieved through chart reviews. The prevalence of types of health care used and remaining needs related to medical, psychosocial, paramedical and supplementary service care (such as home care), was examined with descriptive analyses. RESULTS: Seven hundred forty-six women completed both questionnaires. At both assessments patients reported that they had most frequent contact with medical and paramedical providers, independent of types of treatment received. Three to fifteen percent of the patients expressed a need for more support. Prominent needs included a wish for more frequent contact with a physiotherapist, a clinical geneticist and a psychologist. Patients also wanted more help for chores around the house, particularly in the early post-treatment phase. CONCLUSION: A small but relevant percentage of women with breast cancer report having unmet needs. GPs may need to be particularly watchful of their need for more support from specific providers. Future research into the necessity of structural needs assessment among cancer patients in general practice is warranted.

Risk factors of unmet needs among women with breast cancer in the post-treatment phase.

OBJECTIVE: Unmet health care needs require additional care resources to achieve optimal patient well-being. In this nationwide study we examined associations between a number of risk factors and unmet needs after treatment among women with breast cancer, while taking into account their health care practices. We expected that more care use would be associated with lower levels of unmet needs. METHODS: A multicenter, prospective, observational design was employed. Women with primary breast cancer completed questionnaires 6 and 15 months post-diagnosis. Medical data were retrieved from medical records. Direct and indirect associations between sociodemographic and clinical risk factors, distress, care use, and unmet needs were investigated with structural equation modeling. RESULTS: Seven hundred forty-six participants completed both questionnaires (response rate 73.7%). The care services received were not negatively associated with the reported levels of unmet needs after treatment. Comorbidity was associated with higher physical and daily living needs. Higher age was associated with higher health system-related and informational needs. Having had chemotherapy and a mastectomy were associated with higher sexuality needs and breast cancer-specific issues, respectively. A higher level of distress was associated with higher levels of unmet need in all domains. CONCLUSIONS: Clinicians may use these results to timely identify which women are at risk of developing specific unmet needs after treatment. Evidence-based, cost-effective (online) interventions that target distress, the most influential risk factor, should be further implemented and disseminated among patients and clinicians.

Quantitative assessment of biliary stent artifacts on MR images: Potential implications for target delineation in radiotherapy.

PURPOSE: Biliary stents may cause susceptibility artifacts, gradient-induced artifacts, and radio frequency (RF) induced artifacts on magnetic resonance images, which can hinder accurate target volume delineation in radiotherapy. In this study, the authors investigated and quantified the magnitude of these artifacts for stents of different materials. METHODS: Eight biliary stents made of nitinol, platinum-cored nitinol, stainless steel, or polyethylene from seven vendors, with different lengths (57-98 mm) and diameters (3.0-11.7 mm), were placed in a phantom. To quantify the susceptibility artifacts sequence-independently, ΔB0-maps and T2∗-maps were acquired at 1.5 and 3 T. To study the effect of the gradient-induced artifacts at 3 T, signal decay in images obtained with maximum readout gradient-induced artifacts was compared to signal decay in reference scans. To quantify the RF induced artifacts at 3 T, B1-maps were acquired. Finally, ΔB0-maps and T2∗-maps were acquired at 3 T of two pancreatic cancer patients who had received platinum-cored nitinol biliary stents. RESULTS: Outside the stent, susceptibility artifacts dominated the other artifacts. The stainless steel stent produced the largest susceptibility artifacts. The other stents caused decreased T2∗ up to 5.1 mm (1.5 T) and 8.5 mm (3 T) from the edge of the stent. For sequences with a higher bandwidth per voxel (1.5 T: BWvox > 275 Hz/voxel; 3 T: BWvox > 500 Hz/voxel), the B0-related susceptibility artifacts were negligible (<0.2 voxels). The polyethylene stent showed no artifacts. In vivo, the changes in B0 and T2∗ induced by the stent were larger than typical variations in B0 and T2∗ induced by anatomy when the stent was at an angle of 30° with the main magnetic field. CONCLUSIONS: Susceptibility artifacts were dominating over the other artifacts. The magnitudes of the susceptibility artifacts were determined sequence-independently. This method allows to include additional safety margins that ensure target irradiation.

Predictors of enduring clinical distress in women with breast cancer.

To date, little is known about enduring clinical distress as measured with the commonly used distress thermometer. We therefore used the distress thermometer to examine: (a) the prevalence of enduring clinical distress, distress-related problems, and subsequent wish for referral of women with breast cancer, and (b) sociodemographic, clinical, and psychosocial predictors of enduring clinical distress. The study had a multicenter, prospective, observational design. Patients with primary breast cancer completed a questionnaire at 6 and 15 months postdiagnosis. Medical data were retrieved from chart reviews. Enduring clinical distress was defined as heightened distress levels over time. The prevalence of enduring clinical distress, problems, and wish for referral was examined with descriptive analyses. Associations between predictors and enduring clinical distress were examined with multivariate analyses. One hundred sixty-four of 746 patients (22 %) reported having enduring clinical distress at 6 and 15 months postdiagnosis. Of these, 10 % wanted to be referred for care. Fatigue was the most frequently reported problem by patients with and without clinical distress, at both time points. Lack of muscle strength (OR = 1.82, 95 % CI 1.12-2.98), experience of a low level of life satisfaction (OR = 0.77, 95 % CI 0.67-0.89), more frequent cancer worry (OR = 1.40, 95 % CI 1.05-1.89), and neuroticism (OR = 1.09, 95 % CI 1.00-1.18) were predictors of enduring clinical distress. In conclusion, one in five women with breast cancer develops enduring clinical distress. Oncologists, nurse practitioners, and cancer nurses are advised to use single-item questions about distress and distress-related problems to ensure timely detection of high-risk patients. Providers should also routinely assess fatigue and its causes, as fatigue is the most frequently reported distress-related problem over time.

Don't forget the dentist: Dental care use and needs of women with breast cancer.

PURPOSE: Patients with breast cancer may develop dental problems due to treatment. We examined the prevalence of their dental care use and needs, compared the prevalence of use with that of the general population, and examined which factors predict patients' dental care use. METHODS: Patients with primary breast cancer completed a questionnaire at 6 and 15 months post-diagnosis. Medical data were retrieved from medical records. The prevalence of dental care use and needs was examined with descriptive analyses. Associations between predictors and dental care use were examined with multivariate analyses. RESULTS: Twenty-one percent of 746 participants visited their dentist at least once in the past three months at 6 months, and 23% at 15 months post-diagnosis. The estimated percentage of women with at least one contact with their dentist in 12 months was low compared to the general female population (31.9% versus 79.5%). One to two percent of the respondents wanted more contact. Having dental care insurance (odds ratio 1.80; 95% CI, 1.08-3.00), chemotherapy (odds ratio 1.93; 95% CI, 1.21-3.06), and clinical distress 6 months post-diagnosis (odds ratio 2.53; 95% CI, 1.70-3.79) predicted use of dental care 9 months later. CONCLUSIONS: Up to 15 months post-diagnosis, breast cancer patients' dental care use is lower than warranted. Oncologists and cancer nurses are recommended to inform patients about dental risks, and to encourage them - particularly those without insurance - to visit their dentist. Occurrence of dental problems should be monitored, especially in patients who receive chemotherapy or who are clinically distressed.

Guidelines for time-to-event end-point definitions in trials for pancreatic cancer. Results of the DATECAN initiative (Definition for the Assessment of Time-to-event End-points in CANcer trials).

BACKGROUND: Using potential surrogate end-points for overall survival (OS) such as Disease-Free- (DFS) or Progression-Free Survival (PFS) is increasingly common in randomised controlled trials (RCTs). However, end-points are too often imprecisely defined which largely contributes to a lack of homogeneity across trials, hampering comparison between them. The aim of the DATECAN (Definition for the Assessment of Time-to-event End-points in CANcer trials)-Pancreas project is to provide guidelines for standardised definition of time-to-event end-points in RCTs for pancreatic cancer. METHODS: Time-to-event end-points currently used were identified from a literature review of pancreatic RCT trials (2006-2009). Academic research groups were contacted for participation in order to select clinicians and methodologists to participate in the pilot and scoring groups (>30 experts). A consensus was built after 2 rounds of the modified Delphi formal consensus approach with the Rand scoring methodology (range: 1-9). RESULTS: For pancreatic cancer, 14 time to event end-points and 25 distinct event types applied to two settings (detectable disease and/or no detectable disease) were considered relevant and included in the questionnaire sent to 52 selected experts. Thirty experts answered both scoring rounds. A total of 204 events distributed over the 14 end-points were scored. After the first round, consensus was reached for 25 items; after the second consensus was reached for 156 items; and after the face-to-face meeting for 203 items. CONCLUSION: The formal consensus approach reached the elaboration of guidelines for standardised definitions of time-to-event end-points allowing cross-comparison of RCTs in pancreatic cancer.